Surgically implanted endovascular, microaxial left ventricular assist device: A single institution study.

Objective: The Impella 5.5 (Abiomed, Inc), a surgically implanted endovascular microaxial left ventricular assist device, is increasingly used worldwide and there have been more than 10,000 implants. The purpose of this study is to describe a large-volume, single-center experience with the use of the Impella 5.5. Methods: Data were obtained retrospectively from patients supported with the Impella 5.5 implanted at our institution from May 1, 2020, to December 31, 2022. Demographic, operative, and postoperative outcomes for each group are described. Results are reported in median (interquartile range) or n (%). The entire cohort was divided into 5 main groups based on the intention to treat at the time of the Impella 5.5 implantation: (1) patients who had a planned Impella 5.5 implanted at the time of high-risk cardiac surgery; (2) patients with cardiogenic shock; (3) patients bridged to a durable left ventricular assist device; (4) patients bridged to transplant; and (5) patients with postcardiotomy shock who received an unplanned Impella 5.5 implant. Results: A total of 126 patients were supported with the Impella 5.5. Overall survival to device explant was 76.2%, with 67.5% surviving to discharge. Midterm survival was assessed with a median follow-up time of 318 days and demonstrated an overall survival of 60.3% and a median of 650 days (549-752). Conclusions: Outcomes after using the Impella 5.5 are variable depending on the indication of use. Patient selection may be of utmost importance and requires further experience with this device to determine who will benefit from insertion.

Characterization of de novo malignancy after orthotopic heart transplantation: single-centre outcomes over 20 years.

OBJECTIVES: Malignancy is the leading cause of late mortality after orthotopic heart transplantation (OHT), and the burden of post-transplantation cancer is expected to rise in proportion to increased case volume following the 2018 heart allocation score change. In this report, we evaluated factors associated with de novo malignancy after OHT with a focus on skin and solid organ cancers. METHODS: Patients who underwent OHT at our institution between 1999 and 2018 were retrospectively reviewed (n = 488). Terminal outcomes of death and development of skin and/or solid organ malignancy were assessed as competing risks. Fine-Gray subdistribution hazards regression was used to evaluate the association between perioperative patient and donor characteristics and late-term malignancy outcomes. RESULTS: By 1, 5 and 10 years, an estimated 2%, 17% and 27% of patients developed skin malignancy, while 1%, 5% and 12% of patients developed solid organ malignancy. On multivariable Fine-Gray regression, age [1.05 (1.03-1.08); P < 0.001], government payer insurance [1.77 (1.20-2.59); P = 0.006], family history of malignancy [1.66 (1.15-2.38); P = 0.007] and metformin use [1.73 (1.15-2.59); P = 0.008] were associated with increased risk of melanoma and basal or squamous cell carcinoma. Age [1.08 (1.04-1.12); P < 0.001] and family history of malignancy [2.55 (1.43-4.56); P = 0.002] were associated with an increased risk of solid organ cancer, most commonly prostate and lung cancer. CONCLUSIONS: Vigilant cancer and immunosuppression surveillance is warranted in OHT recipients at late-term follow-up. The cumulative incidence of skin and solid organ malignancies increases temporally after transplantation, and key risk factors for the development of post-OHT malignancy warrant identification and routine monitoring.

Cannulation Strategy for Extracorporeal Membrane Oxygenation Does Not Influence Total Hospital Cost.

BACKGROUND: The Center for Medicare and Medicaid Services decreased reimbursement rates for peripheral venoarterial (VA) extracorporeal membrane oxygenation (ECMO) and venovenous (VV) ECMO procedures in October 2018. Limited data are available describing hospital costs and clinical resources required to support ECMO patients. METHODS: All patients supported on ECMO at our institution between March 2017 and October 2018 were identified. Exclusion criteria were cannulation at referring hospitals, organ transplant recipients, and temporary right ventricular support. The cohort was stratified by the initial cannulation strategy. Outcomes were total hospital cost and clinical resource utilization. RESULTS: There were 29 patients supported on central VA, 72 on peripheral VA, and 37 on VV ECMO. Survival at 30 days was 48% for central vs 37% for peripheral vs 51% for VV. Hospital costs were $187,848 for central vs $178,069 for peripheral vs $172,994 for VV (P = .91). Mean hospital stay was 25.8 days for central vs 21.5 days for peripheral vs 26.2 days for VV (P = .49). Mean intensive care unit stay was 14.1 days for central vs 12.8 days for peripheral vs 7.7 days for VV (P = .25). Mean length of ECMO support was 6.5 days for central vs 6.2 days for peripheral vs 7.8 days for VV (P = .38). Mean ventilator time was 13.0 days for central vs 8.2 days for peripheral vs 10.0 days for VV (P = .06). Hemodialysis was used in 41% central patients, 47% peripheral, and 41% VV (P = .75). Theoretical ECMO reimbursement losses ranged from $1,970,698 to $5,648,219 annually under 2018 Center for Medicare and Medicaid Services rates. CONCLUSIONS: ECMO cannulation strategy has minimal impact on resource utilization and hospital cost.

Observed to expected 30-day mortality as a benchmark for transcatheter aortic valve replacement.

OBJECTIVE: The observed-to-expected 30-day mortality ratio (O:E ratio) is a standard metric by which transcatheter aortic valve replacement (TAVR) trials have been evaluated. Early TAVR trials consistently demonstrated O:E ratio less than 0.6 after TAVR when based on the Society for Thoracic Surgery Predicted Risk of Mortality (STS-PROM) for surgical aortic valve replacement. Recent published results from the Transcatheter Valve Therapy (TVT) Registry have demonstrated O:E ratios of 1.0. We evaluated our own O:E ratios for TAVR to investigate this discordance. METHODS: Data were collected prospectively for TAVR patients from 2008 through 2015 (N = 546) and were reviewed retrospectively. The observed mortality and STS-PROM were calculated to formulate O:E ratios and were compared over a variety of subgroups. RESULTS: Overall, the O:E ratio for 30-day mortality was 0.4 and significantly less than 1 (P < .001; 95% confidence interval, 0.25-0.63). The O:E ratio relationship remained less than 0.5 for patients with low (STS-PROM < 4), moderate (STS-PROM = 4-8) and high risk (STS-PROM > 8). The O:E ratio was significantly higher for transapical patients (O:E ratio = 0.8) when compared with transfemoral patients (O:E ratio = 0.2). Lastly, O:E ratios for both commercial (O:E ratio = 0.5) and research (O:E ratio = 0.3) patients were similar (P = .337), and both were significantly less than 1 (P = .007 and P < .001, respectively). CONCLUSIONS: The STS-PROM consistently overestimated 30-day mortality after TAVR. Achieving an O:E ratio less than 0.6 may be a realistic goal for all TAVR programs. While an accurate and specific risk calculator for 30-day mortality after TAVR remains to be established, our data suggest that current TVT results are not acceptable for commercial TAVR and that programs with an O:E ratio greater than 0.6, based on the STS-PROM, should reevaluate internal processes to improve their results.

Learning Alternative Access Approaches for Transcatheter Aortic Valve Replacement: Implications for New Transcatheter Aortic Valve Replacement Centers.

BACKGROUND: Smaller transcatheter aortic valve replacement (TAVR) delivery systems have increased the number of patients eligible for transfemoral procedures while decreasing the need for transaortic (TAo) or transapical (TA) access. As a result, newer TAVR centers are likely to have less exposure to these alternative access techniques, making it harder to achieve proficiency. The purpose of this study was to evaluate the learning curve for TAVR approaches and compare perioperative outcomes. METHODS: From January 2008 to December 2014, 400 patients underwent TAVR (transfemoral, n = 179; TA, n = 120; and TAo, n = 101)). Learning curves were constructed using metrics of contrast utilization, procedural, and fluoroscopy times. Outcomes during the learning curve were compared with after proficiency was achieved. RESULTS: Depending on the metric, learning curves for all three routes differed slightly but all demonstrated proficiency by the 50th case. There were no significant differences in procedural times whereas improvements in contrast use were most notable for TA (69 ± 40 mL versus 50 ± 23 mL, p = 0.002). For both TA and TAo, fewer patients received transfusions once proficiency was reached (62% versus 34%, p = 0.003, and 42% versus 14%, p = 0.002, respectively). No differences in 30-day or 1-year mortality were seen before or after proficiency was reached for any approach. CONCLUSIONS: The learning curves for TA and TAo are distinct but technical proficiency begins to develop by 25 cases and becomes complete by 50 cases for both approaches. Given the relatively low volume of alternative access, achieving technical proficiency may take significant time. However, technical proficiency had no effect on 30-day or 1-year mortality for any access approach.

Delirium after surgical and transcatheter aortic valve replacement is associated with increased mortality.

OBJECTIVE: The purpose of this study was to determine the incidence and clinical significance of postoperative delirium (PD) in patients with aortic stenosis undergoing surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). METHOD: Between 2010 and 2013, 427 patients underwent TAVR (n = 168) or SAVR (n = 259) and were screened for PD using the Confusion Assessment Method for the Intensive Care Unit. The incidence of PD in both treatment groups was determined and its association with morbidity and mortality was retrospectively compared. RESULTS: PD occurred in 135 patients (32%) with a similar incidence between SAVR (33% [86 out of 259]) and TAVR (29% [49 out of 168]) (P = .40). TAVR by transfemoral approach had the lowest incidence of PD compared with SAVR (18% vs 33%; P = .025) or TAVR when performed by alternative access techniques (18% vs 35%; P = .02). Delirium was associated with longer initial intensive care unit stay (70 vs 27 hours), intensive care unit readmission (10% [14 out of 135] vs 2% [6 out of 292]), and longer hospital stay (8 vs 6 days) (P < .001 for all). PD was associated with increased mortality at 30 days (7% vs 1%; P < .001) and 1 year (21% vs 8%; P < .001). After multivariable adjustment, PD remained associated with increased 1-year mortality (hazard ratio, 3.02; 95% confidence interval, 1.75-5.23; P < .001). There was no interaction between PD and aortic valve replacement approach with respect to 1-year mortality (P = .12). Among propensity-matched patients (n = 170), SAVR-treated patients had a higher incidence of PD than TAVR-treated patients (51% vs 29%; P = .004). CONCLUSIONS: PD occurs commonly after SAVR and TAVR and is associated with increased morbidity and mortality. Given the high incidence of PD and its associated adverse outcomes, further studies are needed to minimize PD and potentially improve patient outcomes.

Preoperative pulmonary function tests predict mortality after surgical or transcatheter aortic valve replacement.

OBJECTIVES: To determine the role of preoperative pulmonary function tests (PFTs) in patients with aortic stenosis (AS) evaluated for aortic valve replacement (AVR), and to evaluate the association between lung disease and mortality in specific subgroups. METHODS: Between 2008 and 2013, 535 patients with preoperative PFTs underwent AVR (transcatheter AVR [TAVR], n = 246; surgical AVR [SAVR], n = 289). The severity of lung disease determined by the Society of Thoracic Surgeons (STS) definition was evaluated in those with and without a clinical suspicion for lung disease (smoking, inhaled steroids/bronchodilators, or home oxygen). The association between lung disease and 1-year mortality was evaluated. RESULTS: Of the 186 patients (35%) without suspected lung disease, 39 (21%) had moderate/severe lung disease by PFT analysis. Among all patients, 1-year mortality was 12% in those with no lung disease, 17% in those with no mild lung disease, 22% in those with moderate lung disease, and 31% in those with severe lung disease (P < .001, log-rank test). After adjustment, moderate/severe lung disease was associated with increased 1-year mortality (adjusted hazard ratio, 2.07; 95% confidence interval, 1.30-3.29; P = .002); this association was not altered by smoking history, suspicion of lung disease, New York Heart Association class, or AVR type (interaction P value nonsignificant for all). CONCLUSIONS: In patients with AS evaluated for AVR, the STS risk score is significantly influenced by the severity of lung disease, which is determined predominantly by PFT results. Even when lung disease is not suspected, PFTs are abnormal in many patients undergoing AVR. Moderate/severe lung disease, diagnosed predominantly by PFTs, is an independent predictor of mortality after SAVR or TAVR. Collectively, these findings suggest that PFTs should be a routine part of the risk stratification of patients considered for AVR.

The "hierarchical" Scratch Collapse Test for identifying multilevel ulnar nerve compression.

BACKGROUND: The Scratch Collapse Test (SCT) is used to assist in the clinical evaluation of patients with ulnar nerve compression. The purpose of this study is to introduce the hierarchical SCT as a physical examination tool for identifying multilevel nerve compression in patients with cubital tunnel syndrome. METHODS: A prospective cohort study (2010-2011) was conducted of patients referred with primary cubital tunnel syndrome. Five ulnar nerve compression sites were evaluated with the SCT. Each site generating a positive SCT was sequentially "frozen out" with a topical anesthetic to allow determination of both primary and secondary ulnar nerve entrapment points. The order or "hierarchy" of compression sites was recorded. RESULTS: Twenty-five patients (mean age 49.6 ± 12.3 years; 64 % female) were eligible for inclusion. The primary entrapment point was identified as Osborne's band in 80 % and the cubital tunnel retinaculum in 20 % of patients. Secondary entrapment points were also identified in the following order in all patients: (1) volar antebrachial fascia, (2) Guyon's canal, and (3) arcade of Struthers. CONCLUSION: The SCT is useful in localizing the site of primary compression of the ulnar nerve in patients with cubital tunnel syndrome. It is also sensitive enough to detect secondary compression points when primary sites are sequentially frozen out with a topical anesthetic, termed the hierarchical SCT. The findings of the hierarchical SCT are in keeping with the double crush hypothesis described by Upton and McComas in 1973 and the hypothesis of multilevel nerve compression proposed by Mackinnon and Novak in 1994.

Quantification of the functional consequences of atrial fibrillation and surgical ablation on the left atrium using cardiac magnetic resonance imaging.

OBJECTIVES: The effect of atrial fibrillation (AF) on left atrial (LA) function has not been well defined and has been largely based on limited echocardiographic evaluation. This study examined the effect of AF and a subsequent Cox-Maze IV (CMIV) procedure on atrial function. METHODS: Cardiac magnetic resonance imaging (cMRI) was performed in 20 healthy volunteers, 8 patients with paroxysmal atrial fibrillation (PAF) and 7 patients with persistent or long-standing persistent atrial fibrillation (LSP AF). Six of the PAF patients underwent surgical ablation with the CMIV procedure and 5 underwent both pre- and postoperative cMRIs. The persistent or LSP AF patients underwent only postoperative cMRIs because all scans were performed with patients in normal sinus rhythm. Volume-time curves throughout the cardiac cycle and regional wall shortening were evaluated using the cine images and compared across groups. RESULTS: Compared with normal volunteers, patients with PAF had significantly decreased reservoir contribution to left ventricular (LV) filling (P = 0.0010), an increased conduit function contribution (P = 0.04) and preserved booster pump function (P = 0.14). Following the CMIV procedure, significant reductions were noted with respect to reservoir and booster pump function, with corresponding increases in conduit function. These differences were more drastic in patients with persistent/LSP AF. Regional wall motion was significantly reduced by PAF in all wall segments (P < 0.05), but was not further reduced by the CMIV. Despite changes in LA function, LV function was preserved following surgery. CONCLUSIONS: PAF significantly altered LA function and has a detrimental effect on regional wall motion. Surgical intervention further altered LA function, but the reasons for this are likely multifactorial and not entirely related to the lesion set itself.